Your Path to ISO 13485 Certification
Elevate your auditing skills with APEX Consulting Group’s ISO 13485 Lead Auditor Training. This specialized course prepares professionals to lead audits in the medical device sector, ensuring compliance with ISO 13485 standards.
Through immersive training sessions, practical case studies, and guidance from experienced instructors, you’ll gain the skills needed to effectively audit and implement ISO 13485 requirements. Earning this certification not only strengthens your auditing capabilities but also positions you as a key contributor to ensuring the highest standards of quality management within the medical device industry.
Become a Certified ISO 13485 Lead Auditor
Click here to Register for ISO 13485 Now
Why choose apex for your ISO 13485 certification?
Real World Scenarios
Engage in practical exercises and case studies that simulate real auditing challenges and solutions.
Experienced Instructors
Benefit from the expertise of seasoned professionals who bring valuable industry experience and knowledge.
Certification
Upon successful completion, receive a certificate recognizing your ability to lead ISO 13485 audits, enhancing your professional credibility.
WHICH ISO 13485 TRAINING COURSE IS RIGHT FOR ME?
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ISO 13485 LEAD AUDITOR
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ISO 13485 INTERNAL AUDITOR
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ISO 13485 FOUNDATIONS
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Content
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ISO 13485 Lead Auditor training course objectives are geared toward those who are planning to manage audit teams and lead an audit program
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ISO 13485 Internal Auditor training course objectives are geared toward those who are planning on scheduling internal audit programs for medical devices
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ISO 13485 Foundations training course objectives are geared toward those who are seeking an introduction to medical devices
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Work Sessions
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18 Activities
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16 Activities
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12 Activities
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Timed Exam
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1.5 hours
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2 hours
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2 hours
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Participant Criteria
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Participation
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Verbal Communication
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Written Reports
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Achieve Objectives for Course
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Content | Course objectives geared towards those who are planning to manage audit teams and lead an audit program |
Work Sessions | 18 Activities |
Timed Exam | 1.5 hours |
Participant Criteria | Participation Verbal Communication Written Reports Achieve Objectives for Course |
Content | Course objectives geared towards those who are planning on scheduling internal audit programs for quality medical devices |
Work Sessions | 16 Activities |
Timed Exam | 2 hours |
Participant Criteria | Participation Verbal Communication Written Reports Achieve Objectives for Course |
Content | Course objectives geared towards those who are seeking an introduction to medical devices |
Work Sessions | 12 Activities |
Timed Exam | 2 hours |
Participant Criteria | Participation Verbal Communication Written Reports Achieve Objectives for Course |
What industries do our ISO 13485 courses apply to?
Our ISO 13485 certification course is designed for individuals who work in industries involved in the design, production, installation, and servicing of medical devices. This includes businesses involved in pharmaceuticals, biotechnology, and healthcare suppliers. The ISO 13485 standard ensures that these organizations meet stringent quality management and safety requirements, which are critical for quality patient care, customer safety, and meeting regulatory requirements.
At APEX Consulting Group, our ISO 13485 instructors bring industry-specific expertise and hands-on experience to help professionals and organizations excel in this highly regulated field. Our trainers have extensive backgrounds in medical device quality systems, auditing, and compliance.
Register for ISO 13485
Take your next step towards certification by registering for one of our upcoming ISO 13485 trainings below. Join the ranks of professionals dedicated to improving patient safety and product quality through ISO 13485 compliance.